Treatment of colds, flu like infections and other general nasal based infections with a solution containing iodine and other broad spectrum microbicides and a method for its use

ABSTRACT

The invention relates generally to a method which utilizes iodine as a broad spectrum microbicide wherein the active agent may be applied in nasal passages in the manner of a decongestant type nose spray. The spray is intended particularly for human use. It is to be applied in the event of known or suspected exposure of the individual to common cold virus, flu, or other infective microbial agents including for example, bacteria, viruses, rickettsia, and even mold and fungus. The active agent is based on an iodine solution and may also contain one or more of the following: sodium hypochlorite solution, or a solution of chlorine or hypochlorites plus a salt of chloride, bromide or iodide. Alternatively, the solution may further contain iodine and a bromine solution, or a solution of iodine, bromine plus a salt of chloride, bromide or iodide such as sodium chloride, zinc chloride, sodium bromide, zinc bromide, sodium iodide or zinc iodide. The iodine, chlorine, hypochlorites, bromine, chloride, bromide, and iodide may originally come from inorganic compounds or organic compounds, which are then dissolved in the water. Further, the solution may contain glycerin or another moisturizing or wetting agent for the nasal mucosa since the halogens or halides may be dehydrating or drying. Zinc gluconate or a zinc halide such as zinc chloride, zinc bromide or zinc iodide may also be included to further render the nasal mucosa more slippery and thus render it more difficult for invading microbes to colonize the area.

[0001] THIS PATENT APPLICATION IS BASED UPON U.S. PROVISIONAL APPLICATION SERIAL No. 60/365,926, FILED Mar. 20, 2002

FIELD OF THE INVENTION

[0002] This invention relates generally to the application of an aqueous nasal solution for use in treatment of (and also the prevention of) infection by microbes (like a head cold, flu, or other infection) by using the broad-spectrum microbicide, iodine, and may also contain one or more of the following: aqueous chlorine or bromine, hypochlorite ion and/or chloride, bromide or iodide ion.

SUMMARY OF THE INVENTION

[0003] The invention relates generally to the use of (or application) of an aqueous solution that contains the broad spectrum microbicide, iodine, which may be applied in nasal passages in the manner of a decongestant type nose spray. The spray is intended particularly for human use. It is to be applied in the event of known or suspected exposure of the individual to common cold virus, flu, or other infective microbial agents including for example, bacteria, viruses, rickettsia, and even mold and fungus. It may also be applied when there is a pre-existing infection caused by the previously mentioned agents. The solution contains an active agent that is based on an iodine solution and may also contain one or more of the following: sodium hypochlorite solution, or a solution of chlorine or hypochlorites plus a salt of chloride, bromide or iodide. Alternatively, the solution may contain iodine plus a bromine solution, or a solution of iodine, bromine plus a salt of chloride, bromide or iodide such as sodium chloride, zinc chloride, sodium bromide, zinc bromide, sodium iodide or zinc iodide. The iodine, chlorine, hypochlorites, bromine, chloride, bromide, and iodide may originally come from inorganic compounds or organic compounds, which are then dissolved in the water. Further, the solution may contain glycerin or another moisturizing or wetting agent for the nasal mucosa since the halogens or halides may be dehydrating or drying. Zinc gluconate or a zinc halide such as zinc chloride, zinc bromide or zinc iodide may also be included to further render the nasal mucosa more slippery and thus render it more difficult for invading microbes to colonize the area.

BACKGROUND OF THE INVENTION

[0004] Cold viruses or other microbes are sometimes transmitted by aerosol such as by a water droplet that is dispersed by coughing or sneezing, or by personal contact including, for example, hand to hand contact where a handshake transfers the microbes from one person to another and then the contaminated hand is brought into the vicinity of the individual's nose. (As when touching the nose or scratching it or rubbing it.) It is generally believed that infective agents will grow and multiply in regions where they have the proper temperature, nutrients, and other conditions conducive to growth or multiplication such as in the nasal mucosa. Thus, an object of the present invention is to apply a broad-spectrum microbicide like iodine to the area where infective viruses may be transmitted or transported, and would ordinarily multiply

[0005] A number of explanations could be proposed for the effectiveness of the microbicide in reducing the risk of full-blown infection. For example, the composition may act to kill the microbe, or to render it ineffective. Further, the microbicide may act to slow diffusion into a cell by tagging it with a heavy ion. This slowing of diffusion may slow the microbe's multiplication and allow the body's natural defenses to catch up and eliminate the microbes. Further, the nasal solution may dilute the attacking organism and wash it out away from the optimum area for growth so as to weaken the statistical probability of success of the infection.

[0006] It is thus an object of the invention to apply a medical agent to the area of entry of the infection, namely the nose, and specifically the inside of the nose, the nasal fossae and the sinus areas within the nose. This treatment can be remedial so as to inhibit an existing infection, or prophylactic so as to prevent spread into the respiratory system by affecting the microbe in the nose. Thus, in accordance with a method of using the nasal spray, it could be applied as soon as the person has determined that he or she has “caught” a cold. It could also be applied after the person first begins to feel the initial symptoms of catching a cold, such as stuffiness or muscular aches or fever. Or it could be applied prophylactically as soon as a person has been exposed to others who have colds and has real reason to be concerned about catching a cold after such an exposure. Moreover, it could be applied in a similar manner for cases of influenza and other infections for minimizing symptoms and extent of “infection”.

[0007] U.S. Pat. No. 5,897,872 refers to an iodine containing solution for prevention or treatment of sinusitis and nasal congestion. The solution to be administered to the nostrils and presumably the nasal mucosa. Picciano recognizes that sinusitis is a condition that might have been triggered as an outcome of having had a cold or the flu. And he states that the improper drainage triggers sinusitis, and then comments that a bacterial infection develops. In U.S. Pat. No. 5,897,872 the iodine solution is for the treatment of sinusitis and or related conditions associated with or caused by nasal congestion.

[0008] The present invention recognizes something new, namely that an iodine based solution may be of significant utility in the actual treatment of colds, influenza, and other microbial infections that are localized or start out localized in the nasal area. This is because of the incredibly diverse and broad-spectrum anti-microbial activity of iodine, iodides, and other halogens and halides. Iodine, chlorine, bromine, iodides, bromides and chlorides will have anti-microbial activity against bacteria, viruses, and a host of other organisms. In the case of colds, influenza, and other similar infections, the cold or other infection causes the congestion, not the other way around. The microbes easily penetrate deep into the un-congested nasal cavity of a healthy person, start the infection and then cause the congestion, as the body seeks to fight them. The iodine, chlorine, hypochlorite, and bromine, iodides, bromides and chlorides will be effective at combating the actual microbial organisms responsible for colds, influenza and other infections.

DETAILED DESCRIPTION OF THE INVENTION

[0009] One preferred embodiment of the invention comprises an aqueous solution of iodine with a halogen salt such as sodium chloride, sodium bromide, sodium iodide, zinc chloride, zinc bromide or zinc iodide. It may also include more than one of the aforementioned salts. In addition, it may also include zinc gluconate.

[0010] Another preferred embodiment of the invention is an aqueous solution of iodine and of sodium hypochlorite with a halogen salt such as sodium chloride, sodium bromide, sodium iodide, zinc chloride, zinc bromide or zinc iodide. It may also include more than one of the aforementioned salts. In addition, it may also include zinc gluconate.

[0011] And another embodiment of the invention would be an aqueous solution of iodine and chlorine with a halogen salt such as sodium chloride, sodium bromide, sodium iodide, zinc chloride, zinc bromide or zinc iodide. It may also include more than one of the aforementioned salts. In addition, it may also include zinc gluconate.

[0012] Another embodiment of the invention would be an aqueous solution of iodine and bromine with a halogen salt such as sodium chloride, sodium bromide, sodium iodide, zinc chloride, zinc bromide or zinc iodide. It may also include more than one of the aforementioned salts. In addition, it may also include zinc gluconate.

[0013] Another preferred embodiment of the invention is an aqueous solution of bromine with a halogen salt, i.e. chloride, bromide or iodide. The salt may constitute a chloride, a bromide or iodide with a specific example being sodium bromide, or zinc bromide.

[0014] Another embodiment of this invention is the use of organic compounds of chlorine, bromine or iodine, or organic compounds that are chlorides, bromides or iodides. These compounds are such that they decompose in solution or chemically react in order to provide the necessary halogen components for making the aqueous mixture that will be used to spray into the nose onto the nasal mucosa.

[0015] There may be particular advantages of using mixed halogens since they sometimes combine in stable but reactive trimers like I₃—, I₂Cl—, I₂Br—, Br₂Cl—, Br₂I—, etc. Having stabilized the reactive halogen, there will likely be more of the halogen present in the solution for reaction with sensitive areas of the microbes existing on the nasal mucosa.

[0016] It is postulated that these ionic species will react chemically with organic or biological chemicals on or in the virus so as to kill it or render it ineffective. Further, the solutions can contain glycerin or some other additive to act as a moisturizer since the halogen species tend to have a dehydrating, drying effect on the nasal mucosa. The pH could be adjusted, if necessary, to match the pH of mucous membranes or to optimize the activity without being harmful to the nasal mucosa. It can be adjusted up or down using sodium hydroxide, chlorine, sodium hypochlorite, hydrogen chloride, bromine, or hydrogen bromide. Thus, an appropriate pH for the final solution would be from about pH 5.5 to about pH 8.5, and preferably from about pH 6 to pH 8 and more preferably from about pH 6.5 to pH 7.5.

[0017] Iodine would be present at a concentration of about 1 ppmw to about 50,000 ppmw, more preferably from about 10 ppmw to about 5,000 ppmw, and more preferably from about 10 ppmw to about 1600 ppmw. The iodine may be introduced as from a povidone-iodine solution, taking advantage of the well known fact that povidone solutions of iodine are less irritating to tissues than are other iodine solutions. This can be extremely beneficial considering the tissues in the nasal mucosa are much more sensitive to all forms of irritation than are external dermal tissues.

[0018] Sodium hypochlorite would be present in a concentration of about 0.5 ppmw to about 50,000 ppmw, and preferably from about 5 ppmw to about 5000 ppmw and more preferably from about 50 ppmw to 500 ppmw. It may also be potassium or calcium hypochlorite.

[0019] Sodium or potassium chloride would be present in a concentration of about 55 ppmw to 75,000 ppmw, and preferably from 250 ppmw to 50,000 ppmw and more preferably from about 2,500 ppmw to 25,000 ppmw. This could also be magnesium or calcium chloride or other chlorides.

[0020] Sodium or potassium bromide would be present in a concentration of about 0.7 ppmw to about 140,000 ppmw, more preferably from about 140 ppmw to about 55,000 ppmw, and more preferably from about 1,400 ppmw to about 28,000 ppmw. This could also be magnesium or calcium bromide or other bromides.

[0021] Sodium or potassium iodide would be present in a concentration of about 0.1 ppmw to about 160,000 ppmw, more preferably from about 200 ppmw to about 80,000 ppmw, and more preferably from about 2,000 ppmw to about 40,000 ppmw. This could also be magnesium or calcium iodide or other iodides.

[0022] Chlorine would be present at a concentration of about 0.4 ppmw to about 50,000 ppmw, more preferably from about 2 ppmw to about 5000 ppmw, and more preferably from about 10 ppmw to about 500 ppmw.

[0023] Bromine would be present at a concentration of about 1 ppmw to about 75,000 ppmw, more preferably from about 4 ppmw to about 8,000 ppmw, and more preferably from about 20 ppmw to about 1000 ppmw.

[0024] Zinc chloride would be present at a concentration of about 0.4 ppmw to about 50,000 ppmw, more preferably from about 40 ppmw to about 15,000 ppmw, and more preferably from about 400 ppmw to about 5,000 ppmw.

[0025] Zinc bromide would be present at a concentration of about 0.7 ppmw to about 80,000 ppmw, more preferably from about 75 ppmw to about 33,000 ppmw, and more preferably from about 750 ppmw to about 10,000 ppmw.

[0026] Zinc iodide would be present at a concentration of about 1 ppmw to about 120,000 ppmw, more preferably from about 100 ppmw to about 80,000 ppmw, and more preferably from about 1,000 ppmw to about 20,000 ppmw.

[0027] Zinc gluconate would be present at a concentration of about 1.7 ppmw to about 60,000 ppmw, more preferably from about 17 ppmw to about 6,000 ppmw, and more preferably from about 170 ppmw to about 1800 ppmw.

[0028] Glycerine would be present at a concentration of about 0.01 wt. % to about 5 wt. %, more preferably from about 0.04 wt. % to about 2 wt. %, and more preferably from about 0.1 wt. % to about 1 wt. %. Propylene glycol could be used as a substitute for glycerine.

EXAMPLES Example 1

[0029] An example solution was mixed up and used by a 51-year-old male for the alleviation of head cold symptoms, including the typical nasal congestion. The applications were started after the cold had progressed into its early stages. It is not known to what extent the treatments altered the total course of the cold development, including its symptoms and extent. In order to provide a more concrete description of the example, let me list in detail the manner in which the solution was made.

[0030] First of all, Betadine-Iodine, which is a povidone-iodine solution with a povidone-iodine of strength 10%, which has an equivalent free iodine strength of 1%, was obtained. A solution was made up by dissolving 1.5 grams of NaI (sodium iodide) crystals in 45 milliliters of water. Once the solute was thoroughly dissolved, then 3 drops of the 10% povidone-iodine solution (which is 1% free equivalent iodine solution) were added. The solution was thoroughly mixed and put into a nasal spray bottle.

[0031] The spray was administered by spraying 2 to 4 times briskly into the nose while inhaling slightly. This was repeated approximately every 3 to 5 hours as needed. The subject observed a reduction of the mucosa production, as well as a lessening of the irritation of the back of the nose and pharynx, including the tonsils and adenoids. The nose and sinuses continued to decongest with further application of the spray and other cold symptoms such as aches were reduced or alleviated.

Example 2

[0032] An example solution was mixed up and used by a 51-year-old male for the alleviation of head cold symptoms, including the typical nasal congestion. The applications were started after about 2 days into the progress of the cold. It is not known to what extent the treatments altered the total course of the cold development, including its symptoms and extent. In order to provide a more concrete description of the example, let me list in detail the manner in which the solution was made.

[0033] First of all, Betadine-Iodine, which is a povidone-iodine solution with a povidone-iodine of strength 10%, which has an equivalent free iodine strength of 1%, was obtained. A solution was made up by dissolving 1.5 grams of NaI (sodium iodide) crystals in 45 milliliters of water. Once the solute was thoroughly dissolved, then 3 drops of the 10% povidone-iodine solution (which is 1% free equivalent iodine solution) were added. In addition 1 gram of NaCl (sodium chloride) crystals were dissolved in the 45 milliliters of aqueous solution. The solution was thoroughly mixed. Finally, 3 drops of glycerine were added to the solution. The solution was thoroughly mixed again and put into a nasal spray bottle.

[0034] The spray was administered following the same protocol as above and observed the same positive results.

[0035] While in accordance with the patent statutes the best mode and preferred embodiment have been set forth, the scope of the invention is not limited thereto, but rather by the scope of the attached claims. 

1. A method of reducing the risk of microbial infection and of combating an established microbial infection which is established first in the nasal mucosa area comprising the application of a nasal spray solution within the nose, said nasal spray solution comprising an aqueous solution having one or more of the following components: a) iodine at a concentration of about 1 ppmw to about 50,000 ppmw; b) sodium, potassium, or calcium hypochlorite at a concentration of about 0.5 ppmw to about 50,000 ppmw; c) sodium, magnesium, calcium, or potassium chloride at a concentration of about 55 ppmw to 75,000 ppmw; d) sodium, magnesium, calcium, or potassium bromide at a concentration of about 0.7 ppmw to about 140,000 ppmw; e) sodium, magnesium, calcium or potassium iodide at a concentration of about 0.1 ppmw to about 160,000 ppmw; f) chlorine at a concentration of about 0.4 ppmw to about 50,000 ppmw; g) bromine at a concentration of about 1 ppmw to about 75,000 ppmw; h) zinc chloride at a concentration of about 0.4 ppmw to about 50,000 ppmw; i) zinc bromide at a concentration of about 0.7 ppmw to about 80,000 ppmw; j) zinc iodide at a concentration of about 1 ppmw to about 120,000 ppmw; and optionally one or more of k) zinc gluconate at a concentration of about 1.7 ppmw to about 60,000 ppmw and glycerine or propylene gycol at a concentration of about 0.01 wt % to about 5 wt %.
 2. A method of reducing the risk of microbial infection and of combating an established microbial infection which is established first in the nasal mucosa area comprising the application of a nasal spray solution within the nose, said nasal spray solution comprising an aqueous solution having; from about 0.1 ppmw to 160,000 ppmw of a salt selected from one or more of sodium bromide and sodium iodide; from about 55 ppmw to 75,000 ppmw of sodium chloride; from about 1 ppmw to about 50,000 ppmw of iodine; from about 0.01 wt. % to about 5 wt. % of glycerin.
 3. A method of reducing the risk of microbial infection and also of combating an established microbial infection which is established first in the nasal mucosa area comprising the application of a nasal spray solution within the nose, said nasal spray solution comprising an aqueous solution having; from about 0.1 ppmw to about 160,000 ppmw of sodium iodide; and from about 1 ppmw to about 50,000 ppmw of iodine;
 4. A method of reducing the risk of microbial infection and also of combating an established microbial infection which is established first in the nasal mucosa area comprising the application of a nasal spray solution within the nose, said nasal spray solution comprising an aqueous solution having; from about 0.7 ppmw to about 140,000 ppmw of sodium bromide; and from about 1 ppmw to about 50,000 ppmw of iodine;
 5. A method of reducing the risk of microbial infection and also of combating an established microbial infection which is established first in the nasal mucosa area comprising the application of a nasal spray solution within the nose, said nasal spray solution comprising an aqueous solution having; from about 0.1 ppmw to 160,000 ppmw of a salt selected from one or more of sodium bromide and sodium iodide; from about 55 ppmw to 75,000 ppmw of sodium chloride; from about 1 ppmw to about 50,000 ppmw of iodine; from about 0.01 wt. % to about 5 wt. % of glycerin; and from about 1.7 ppmw to about 120,000 ppmw of zinc gluconate or zinc iodide.
 6. A method of reducing the risk of microbial infection and also of combating an established microbial infection which is established first in the nasal mucosa area comprising the application of a nasal spray solution within the nose, said nasal spray solution comprising an aqueous solution having; from about 0.4 ppmw to about 75,000 ppmw of chlorine or bromine; from about 1 ppmw to about 50,000 ppmw of iodine; from about 0.1 ppmw to 160,000 ppmw of a salt selected from one or more of sodium bromide and sodium iodide; from about 55 ppmw to 75,000 ppmw of sodium chloride; from about 0.01 wt. % to about 5 wt. % of glycerin.
 7. A method of reducing the risk of microbial infection and also of combating an established microbial infection which is established first in the nasal mucosa area comprising the application of a nasal spray solution within the nose, said nasal spray solution comprising an aqueous solution having; from about 0.5 ppmw to about 50,000 ppmw of sodium hypochlorite; from about 0.1 ppmw to 160,000 ppmw of a salt selected from one or more of sodium bromide and sodium iodide; from about 55 ppmw to 75,000 ppmw of sodium chloride; from about 1 ppmw to about 50,000 ppmw of iodine; from about 0.01 wt. % to about 5 wt. % of glycerin. 